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Ofatumumab Dose-finding in Relapsing Remitting Multiple Sclerosis (RRMS) Patients (OMS115102)

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ClinicalTrials.gov Identifier: NCT00640328
Recruitment Status : Completed
First Posted : March 21, 2008
Results First Posted : December 4, 2012
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Interventions Drug: Ofatumumab 100
Drug: Ofatumumab 300
Drug: Ofatumumab 700
Drug: Placebo
Enrollment 38
Recruitment Details  
Pre-assignment Details In all 3 dose cohorts, participants in the active/placebo group received treatment with ofatumumab during the First Treatment Period and placebo during the Second Treatment Period. Participants in the placebo/active group received treatment with placebo during the First Treatment Period and ofatumumab during the second treatment period.
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination. Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination. Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination. Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Period Title: First Treatment Period (Weeks 0-24)
Started 8 11 7 4 4 4
Completed 8 10 7 4 4 4
Not Completed 0 1 0 0 0 0
Reason Not Completed
Adverse Event             0             1             0             0             0             0
Period Title: Second Treatment Period (Weeks 24-48)
Started 8 10 7 4 4 4
Completed 8 10 7 4 3 4
Not Completed 0 0 0 0 1 0
Reason Not Completed
Adverse Event             0             0             0             0             1             0
Period Title: IFUP (Week 48 to Individual Termination)
Started 8 11 7 4 4 4
Completed 8 10 6 3 4 4
Not Completed 0 1 1 1 0 0
Reason Not Completed
Withdrawal by Subject             0             0             1             0             0             0
Not Recommended - Informed Consent Form             0             1             0             1             0             0
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa Total
Hide Arm/Group Description Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. Total of all reporting groups
Overall Number of Baseline Participants 8 11 7 4 4 4 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 11 participants 7 participants 4 participants 4 participants 4 participants 38 participants
38.0  (9.0) 36.6  (7.0) 33.7  (8.4) 37.0  (6.5) 27.0  (2.2) 44.0  (8.1) 36.3  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 11 participants 7 participants 4 participants 4 participants 4 participants 38 participants
Female
6
  75.0%
6
  54.5%
4
  57.1%
3
  75.0%
3
  75.0%
0
   0.0%
22
  57.9%
Male
2
  25.0%
5
  45.5%
3
  42.9%
1
  25.0%
1
  25.0%
4
 100.0%
16
  42.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White/Caucasian Number Analyzed 8 participants 11 participants 7 participants 4 participants 4 participants 4 participants 38 participants
8 11 7 4 4 4 38
1.Primary Outcome
Title Number of Participants With Any Adverse Event
Hide Description An Adverse Event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section. Non-serious AEs were not collected during the Individualized Follow-up Period.
Time Frame First Treatment Period (FTP): From Visit 3 (Week 0) up to Visit 10 (Week 24); Second Treatment Period (STP): From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all participants who had been exposed to the investigational product (IP) irrespective of their compliance to the planned course of treatment.
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Overall Number of Participants Analyzed 8 11 7 4 4 4
Measure Type: Number
Unit of Measure: participants
Weeks 0-24 8 10 7 3 2 2
Weeks 24-48 4 5 4 3 4 4
Individualized Follow-up Period 0 0 0 0 0 0
2.Primary Outcome
Title Number of Participants With the Indicated Critical Adverse Events (CAEs)
Hide Description A CAE=treatment-related (TR) grade (G) >=3 AE on day of infusion (inf.) preventing inf. to be resumed, a TR G 3 bronchospasm during 1 inf., an AE whose severity becomes G 3 for the third time during 1 inf., infections reported as serious, a TR neurological event consistent with progressive multifocal leukoencephalopathy (PML), any malignancy, and any fatal adverse drug reaction. AE severity (assessed as G 1-5) was classified using the Common Terminology Criteria for Adverse Events v3.0: G 1=mild AE; G 2=moderate AE; G 3=severe AE; G 4=life-threatening or disabling AE; G 5=death related to AE.
Time Frame FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Overall Number of Participants Analyzed 8 11 7 4 4 4
Measure Type: Number
Unit of Measure: participants
Week 0-24; Influenza 0 0 0 1 0 0
Week 0-24; Bronchospasm 0 1 0 0 0 0
Week 0-24; Cough 0 1 0 0 0 0
Week 0-24; Rash pruritic 0 1 0 0 0 0
Week 24-48; any CAE 0 0 0 0 0 0
Individualized Follow-up Period; any CAE 0 0 0 0 0 0
3.Primary Outcome
Title Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)
Hide Description Participants are checked for negative (or a lack of) HAHA at Baseline, and then throughout the study, to ensure that the investigational product is not causing HAHA development. Participants with concentrations of Ofa that are missing or are above 500 nanograms per milliliter (ng/mL) are considered to have unconfirmed HAHA results.
Time Frame Visit 3 (Week 0), Visit 10 (Week 24), Visit 17 (Week 48) or early withdrawal (EW), and Visit 26 (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Overall Number of Participants Analyzed 8 11 7 4 4 4
Measure Type: Number
Unit of Measure: participants
Week 0; n=8, 8, 2, 4, 3, 4 8 8 2 4 3 4
Week 24; n=8, 9, 1, 4, 4, 4 8 9 1 4 4 4
Week 48 or EW, negative; n=8, 11, 7, 4, 3, 4 8 11 7 4 3 1
Week 48 or EW, unconfirmed, n=8, 11, 7, 4, 3, 4 0 0 0 0 0 3
IFUP, n=8, 11, 7, 4, 4, 4 0 0 0 0 0 0
4.Primary Outcome
Title Number of Participants With Abnormal Physical Examination Findings
Hide Description The investigator performed the physical examination, which included but was not limited to: general appearance and the following body systems: lymph nodes, mouth and throat, lungs, cardiovascular, abdomen, extremities, muscular-skeletal, neurological (apart from multiple sclerosis [a brain and spinal cord disease]), and skin. All abnormal clinically relevant findings such as vein problems (venous varices), disorder of the vertebral column (vertebropathy), increased hearing loss, post operative mark (scar), and chronic skin disorder with no sweat and itching (anhidrotic eczema) were reported.
Time Frame FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Overall Number of Participants Analyzed 8 11 7 4 4 4
Measure Type: Number
Unit of Measure: participants
Week 0-24; Venous varices on legs 1 0 0 0 0 0
Week 0-24; Vertebropathy 1 0 0 0 0 0
Week 0-24; Obesitas 1 0 0 0 0 0
Week 0-24; Increased hearing loss 0 0 1 0 0 0
Week 0-24; Post operative scar 0 0 1 0 0 0
Week 0-24; Anhidrotic eczema 0 0 0 0 0 1
Week 24-48; Venous varices on legs 1 0 0 0 0 0
Week 24-48; Vertebropathy 1 0 0 0 0 0
Week 24-48; Obesitas 1 0 0 0 0 0
Week 24-48; Acne vulgaris 0 1 0 0 0 0
Week 24-48; Post operative scar 0 0 1 0 0 0
IFUP; Any physical examination finding 0 0 0 0 0 0
5.Primary Outcome
Title Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Hide Description Blood samples of participants were collected for hematology assessment. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in basophils, eosinophils, leukocytes, monocytes, lymphocytes, neutrophils, and platelets count was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Week 104 for the IFUP minus the value at Baseline.
Time Frame FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Overall Number of Participants Analyzed 8 10 7 3 4 4
Mean (Standard Deviation)
Unit of Measure: Giga (10^9) per liter
Week 0-24, Basophils; n=7, 10, 7, 3, 3, 4 0  (0) 0  (0) 0  (0) 0  (0) 0  (0) 0  (0)
Week 0-24, Eosinophils; n=8, 10, 6, 2, 3, 4 0  (0.05) -0.05  (0.13) 0.02  (0.15) 0  (0) -0.23  (0.21) 0.03  (0.05)
Week 0-24, Leukocytes; n=8, 10, 7, 3, 4, 4 0.7  (1.6) 0.6  (2.4) -0.1  (3.3) -0.3  (1.6) 0.7  (5.9) 0.4  (0.7)
Week 0-24, Lymphocytes; n=8, 10, 7, 3, 3, 4 0.15  (1.03) -0.36  (0.67) -0.19  (0.78) -0.37  (0.31) -0.60  (0.79) 0.12  (0.21)
Week 0-24, Monocytes; n=8, 10, 7, 3, 3, 4 0.20  (0.31) -0.07  (0.23) 0.00  (0.20) 0.07  (0.06) -0.40  (0.17) 0.05  (0.10)
Week 0-24, Neutrophils; n=8, 10, 7, 3, 3, 4 0.4  (0.9) 1  (2.2) 0  (3.8) -0.1  (1.5) -0.8  (1.7) 0.2  (0.7)
Week 0-24, Platelets; n=8, 10, 7, 3, 4, 4 0.8  (33.3) 10.8  (44.0) 7.6  (39.7) 0.3  (29.5) 5.8  (36.2) -4.8  (34.8)
Week 24-48, Basophils; n=8, 8, 5, 3, 2, 3 0  (0) 0  (0) 0  (0) 0  (0) 0  (0) 0  (0)
Week 24-48, Eosinophils; n=8, 8, 5, 3, 2, 4 0  (0.05) -0.04  (0.16) 0.04  (0.09) -0.07  (0.06) -0.20  (0.28) 0.03  (0.13)
Week 24-48, Leukocytes; n=8, 10, 7, 3, 3, 4 0.5  (1.1) -0.1  (1.7) -0.3  (1.1) -0.9  (0.6) -3.7  (1.7) 0.9  (0.9)
Week 24-48, Lymphocytes; n=8, 8, 6, 3, 2, 4 -0.11  (0.36) -0.28  (0.47) 0.15  (0.36) -0.50  (0.20) -0.65  (0.78) -0.25  (0.45)
Week 24-48, Monocytes; n=8, 8, 6, 3, 2, 4 -0.20  (0.07) -0.01  (0.12) 0.02  (0.17) 0.03  (0.06) -0.04  (0.28) 0.13  (0.25)
Week 24-48, Neutrophils; n=8, 8, 6, 3, 2, 4 0.7  (1.2) 0.2  (1.8) -0.4  (1.0) -0.4  (0.4) -2.9  (1.3) 1.0  (0.7)
Week 24-48, Platelets; n=8, 10, 7, 3, 3, 4 -6.5  (17.3) -16.3  (74.2) -10.1  (14.7) -13.7  (20.6) -34.3  (47.3) -11.0  (38.4)
Week 0-104, Basophils; n=1, 0, 0, 0, 0, 0 0 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Week 0-104, Eosinophils; n=1, 0, 0, 0, 0, 0 0 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Week 0-104, Leukocytes; n=1, 0, 0, 0, 0, 0 1.30 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Week 0-104, Lymphocytes; n=1, 0, 0, 0, 0, 0 -0.60 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Week 0-104, Monocytes; n=1, 0, 0, 0, 0, 0 0 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Week 0-104, Neutrophils; n=1, 0, 0, 0, 0, 0 1.90 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Week 0-104, Platelets; n=1, 0, 0, 0, 0, 0 -20.0 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
[1]
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
[2]
No participants were analyzed in this treatment arm at this time point.
6.Primary Outcome
Title Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Hide Description Blood samples of participants were collected for assessment of erythrocyte count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in erythrocyte count was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Time Frame FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Overall Number of Participants Analyzed 8 10 7 3 4 4
Mean (Standard Deviation)
Unit of Measure: Pico (10^12) per liter
Week 24; n=8, 10, 7, 3, 4, 4 0.06  (0.25) -0.11  (0.33) -0.02  (0.23) -0.09  (0.20) -0.06  (0.42) 0.07  (0.12)
Week 48; n=8, 10, 7, 3, 3, 4 0.05  (0.26) 0.12  (0.34) 0.12  (0.25) 0.01  (0.43) 0.06  (0.18) 0.09  (0.04)
Week 104; n=1, 0, 0, 0, 0, 0 -0.08 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
[1]
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
[2]
No participants were analyzed in this treatment arm at this time point.
7.Primary Outcome
Title Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Hide Description Blood samples of participants were collected for hematocrit assessment. Hematocrit is the percentage of blood volume (BV) that is occupied by red blood cells (RBCs). Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in hematocrit was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline. Hematocrit is measured as a percentage, i.e., volume (V) of red blood cells per volume of blood.
Time Frame FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Overall Number of Participants Analyzed 8 10 7 3 4 4
Mean (Standard Deviation)
Unit of Measure: Percentage of BV occupied by RBCs
Week 24; n=8, 10, 7, 3, 4, 4 -0.00  (0.03) 0.01  (0.03) -0.01  (0.02) -0.02  (0.02) 0.02  (0.04) 0.01  (0.01)
Week 48; n=8, 10, 7, 3, 3, 4 0.01  (0.02) 0.02  (0.03) 0.00  (0.03) 0.01  (0.05) 0.01  (0.01) 0.02  (0.01)
Week 104; n=1, 0, 0, 0, 0, 0 0.01 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
[1]
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
[2]
No participants were analyzed in this treatment arm at this time point.
8.Primary Outcome
Title Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Hide Description Blood samples of participants were collected for assessment of hemoglobin count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in hemoglobin was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Time Frame FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Overall Number of Participants Analyzed 8 10 7 3 4 4
Mean (Standard Deviation)
Unit of Measure: Millimoles/liter
Week 24; n=8, 10, 7, 3, 4, 4 0.1  (0.5) -0.3  (0.7) -0.0  (0.5) -0.4  (0.4) -0.1  (0.8) 0.2  (0.2)
Week 48; n=8, 10, 7, 3, 3, 4 0.1  (0.5) 0.1  (0.7) 0.2  (0.5) -0.3  (1.1) 0.0  (0.3) 0.5  (0.3)
Week 104; n=1, 0, 0, 0, 0, 0 0.10 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
[1]
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
[2]
No participants were analyzed in this treatment arm at this time point.
9.Primary Outcome
Title Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Hide Description Blood samples of participants were collected for assessment of albumin count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 104 for the IFUP) in albumin was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Time Frame FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: VIsit 26 (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Overall Number of Participants Analyzed 8 11 7 4 4 4
Mean (Standard Deviation)
Unit of Measure: grams per liter
Week 24; n=8, 10, 6, 4, 4, 4 -0.6  (2.5) -0.5  (2.5) 1.3  (1.2) -1.6  (3.4) -1.2  (6.1) 2.0  (2.4)
Week 48; n=8, 11, 7, 4, 3, 4 0.1  (2.5) -0.2  (3.1) 1.4  (3.0) -1.1  (5.7) 0.4  (4.0) 1.1  (1.5)
Week 104; n=1, 0, 0, 0, 0, 0 -2.00 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
[1]
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
[2]
No participants were analyzed in this treatment arm at this time point.
10.Primary Outcome
Title Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Hide Description Blood samples of participants were collected for the assessment of alkaline phosphatase, AST, and ALT. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Time Frame FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Overall Number of Participants Analyzed 8 11 7 4 4 4
Mean (Standard Deviation)
Unit of Measure: Units per liter
Week 24, Alkaline phosphatase; n=8, 10, 6, 4, 4, 4 4.8  (9.0) 3.8  (11.9) 2.7  (8.3) 13.0  (20.2) 2.3  (10.6) 8.8  (8.3)
Week 24, AST; n=8, 10, 6, 4, 4, 4 3.6  (5.1) 1.6  (6.3) -0.2  (3.1) -9.5  (28.6) 4.3  (3.2) -1.0  (6.1)
Week 24, ALT; n=8, 10, 6, 4, 4, 4 7.1  (10.2) 4.7  (10.0) -1.7  (6.4) 7.3  (24.4) 5.3  (5.4) 0  (13.0)
Week 48, Alkaline phosphatase; n=8, 11, 7, 4, 3, 4 7.6  (10.7) 3.1  (8.8) 9.1  (12.6) 5.3  (17.7) 5.7  (7.6) 12.5  (12.9)
Week 48, AST; n=8, 11, 7, 4, 3, 4 0.6  (2.6) 1.5  (3.0) 0.3  (2.5) -13.3  (28.5) 0.7  (4.7) 3.3  (10.7)
Week 48, ALT; n=8, 11, 7, 4, 3, 4 2.8  (5.3) 0.6  (4.7) 0.6  (7.4) -4.3  (9.3) 0.7  (8.1) 8.0  (20.4)
Week 104, Alkaline phosphatase; n=1,0,0,0,0,0 16.0 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Week 104, AST; n=1, 0, 0, 0, 0, 0 2.0 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Week 104, ALT; n=1, 0, 0, 0, 0, 0 2.0 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
[1]
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
[2]
No participants were analyzed in this treatment arm at this time point.
11.Primary Outcome
Title Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Hide Description Blood samples of participants were collected for the assessment of bicarbonate, glucose, potassium, and urea. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Time Frame FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before consideAfter completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.ring progression to the 700 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Overall Number of Participants Analyzed 8 11 7 4 4 4
Mean (Standard Deviation)
Unit of Measure: millimoles per liter
Week 24, Bicarbonate; n=8, 10, 6, 4, 4, 4 0.6  (2.2) -1.1  (2.6) -0.6  (2.5) 1.5  (3.2) -2.0  (1.3) -0.6  (4.0)
Week 24, Glucose; n=8, 10, 7, 4, 4, 4 -0.12  (0.59) 0.39  (1.37) 0.64  (1.23) 0.21  (0.42) 0.08  (0.63) -0.22  (0.50)
Week 24, Potassium; n=8, 10, 6, 4, 4, 4 -0.07  (0.35) 0.06  (0.52) 0.03  (0.27) -0.63  (1.01) -0.20  (0.63) -0.00  (0.16)
Week 24, Sodium; n=8, 10, 6, 4, 4, 4 0.4  (2.7) -0.5  (2.8) -1.2  (1.3) 0.5  (1.7) 0.8  (2.1) 0.5  (2.1)
Week 24, Urea; n=8, 10, 6, 4, 4, 4 0.5  (1.6) -0.8  (1.6) 0.4  (1.5) -0.6  (0.8) -0.7  (2.1) -0.1  (0.4)
Week 48, Bicarbonate; n=8, 11, 7, 4, 4, 4 -0.0  (2.9) -0.7  (2.8) 0.6  (1.3) 0.6  (0.2) 1.9  (3.1) 1.0  (2.3)
Week 48, Glucose; n=8, 10, 7, 4, 2, 4 0.10  (0.50) 0.25  (0.95) -0.05  (0.51) 0.09  (0.56) -0.64  (0.44) 0.27  (0.79)
Week 48, Potassium; n=8, 10, 6, 4, 4, 4 4.21  (0.11) 4.43  (0.44) 4.18  (0.34) 4.23  (0.32) 3.98  (0.10) 4.20  (0.32)
Week 48, Sodium; n=8, 11, 7, 4, 3, 4 -2.3  (1.6) -0.07  (3.1) 0.7  (1.0) -0.5  (3.7) -0.7  (1.2) 0.8  (1.0)
Week 48, Urea; n=8, 11, 7, 4, 3, 4 0.13  (1.40) -0.05  (1.32) -0.19  (0.68) -0.30  (1.04) 1.00  (2.20) -0.17  (0.46)
Week 104, Bicarbonate; n=1, 0, 0, 0, 0, 0 -1.00 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Week 104, Glucose; n=1, 0, 0, 0, 0, 0 1.77 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Week 104, Potassium; n=1, 0, 0, 0, 0, 0 0.00 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Week 104, Sodium; n=1, 0, 0, 0, 0, 0 1.00 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Week 104, Urea; n=1, 0, 0, 0, 0, 0 1.00 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
[1]
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
[2]
No participants were analyzed in this treatment arm at this time point.
12.Primary Outcome
Title Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Hide Description Blood samples of participants were collected for the assessment of bilirubin and creatinine. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Time Frame FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Overall Number of Participants Analyzed 8 11 7 4 4 4
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter (µmol/L)
Week 24, Bilirubin; n=8, 10, 5, 4, 4, 4 0.7  (5.2) -0.0  (4.0) 1.2  (2.2) 0.5  (4.0) -2.6  (3.5) 0.3  (5.3)
Week 24, Creatinine; n=8, 10, 6, 4, 4, 4 3.2  (11.8) -0.1  (7.6) 2.5  (4.7) 2.5  (5.7) -2.9  (7.8) -1.2  (4.0)
Week 48, Bilirubin; n=8, 10, 6, 4, 2, 4 1.5  (4.9) -0.1  (4.8) 1.5  (3.5) 0.7  (3.4) -2.8  (1.0) 0.6  (2.8)
Week 48, Creatinine; n=8, 11, 7, 4, 3, 4 3.0  (8.7) -1.9  (5.3) -0.3  (4.1) 3.5  (6.7) -5.0  (6.5) 2.0  (12.5)
Week 104, Bilirubin; n=1, 0, 0, 0, 0, 0 -4.70 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Week 104, Creatinine; n=1, 0, 0, 0, 0, 0 11.5 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
[1]
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
[2]
No participants were analyzed in this treatment arm at this time point.
13.Primary Outcome
Title Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Hide Description Blood samples of participants were collected for the assessment of antibodies produced by B-cells (immunoglobins): immunoglobulin A, immunoglobin G, and immunoglobin M. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Time Frame FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Overall Number of Participants Analyzed 8 10 7 4 4 4
Mean (Standard Deviation)
Unit of Measure: grams per liter
Week 24, IGA; n=8, 10, 6, 4, 4, 4 0.05  (0.16) 0.08  (0.16) 0.40  (0.40) -0.07  (0.18) 0  (0.44) 0.49  (0.35)
Week 24, IGG; n=8, 10, 6, 4, 4, 4 -0.6  (1.0) -0.1  (0.8) 1.2  (1.0) -0.5  (1.0) -0.3  (0.9) 1.4  (0.9)
Week 24, IGM; n=8, 10, 6, 4, 4, 4 -0.09  (0.14) -0.13  (0.39) -0.19  (0.09) 0.25  (0.25) -0.07  (0.19) 0.04  (0.08)
Week 48, IGA; n=8, 11, 7, 4, 3, 4 0.08  (0.24) -0.03  (0.39) 0.13  (0.11) -0.00  (0.24) 0.05  (0.21) 0.29  (0.26)
Week 48, IGG; n=8, 11, 7, 4, 3, 4 -0.8  (1.2) 0.5  (1.6) 1.0  (0.7) -0.6  (1.2) 0.2  (1.6) 1.2  (0.6)
Week 48, IGM; n=8, 11, 7, 4, 3, 4 -0.17  (0.24) -0.21  (0.22) -0.18  (0.24) -0.24  (0.24) -0.40  (0.17) -0.13  (0.04)
Week 104, IGA; n=1, 0, 0, 0, 0, 0 -0.23 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Week 104, IGG; n=1, 0, 0, 0, 0, 0 -0.60 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Week 104, IGM; n=1, 0, 0, 0, 0, 0 -0.07 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
[1]
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
[2]
No participants were analyzed in this treatment arm at this time point.
14.Primary Outcome
Title Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)
Hide Description Maximum (systolic) and minimum (diastolic) BP were assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.
Time Frame FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Overall Number of Participants Analyzed 8 11 7 4 4 4
Mean (Standard Deviation)
Unit of Measure: millimeters of mercury
Week 24, Diastolic BP; n=8, 10, 7, 4, 4, 4 5.3  (11.2) -2.3  (11.1) -5.4  (9.7) -3.5  (7.2) 4.0  (4.9) -1.8  (2.2)
Week 24, Systolic BP; n=8, 10, 7, 4, 4, 4 11.0  (19.7) -2.5  (12.3) -3.1  (14.2) 1.5  (11.3) 1.0  (9.0) -6.5  (9.5)
Week 48, Diastolic BP; n=8, 11, 7, 4, 3, 4 6.6  (4.6) 2.1  (12.0) 0.1  (7.8) 3.0  (4.7) 3.3  (5.8) 6.0  (5.8)
Week 48, Systolic BP; n=8, 11, 7, 4, 3, 4 2.0  (14.5) -2.5  (13.9) -4.9  (8.2) -2.3  (7.4) 1.7  (10.4) 4.5  (1.0)
15.Primary Outcome
Title Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)
Hide Description The pulse rate of each participant was assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.
Time Frame FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Overall Number of Participants Analyzed 8 11 7 4 4 4
Mean (Standard Deviation)
Unit of Measure: beats per minute
Week 24; n=8, 10, 7, 4, 4, 4 -0.3  (11.5) 1.6  (8.4) 0.6  (10.7) 1.3  (13.8) 2.0  (8.0) 3.8  (8.1)
Week 48; n=8, 11, 7, 4, 3, 4 -0.1  (9.8) 0.4  (11.9) -3.0  (10.7) -5.5  (10.0) -0.3  (9.5) 8.0  (5.0)
16.Primary Outcome
Title Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)
Hide Description The temperature of each participant was assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.
Time Frame FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Overall Number of Participants Analyzed 8 11 7 4 4 4
Mean (Standard Deviation)
Unit of Measure: Degrees Celsius
Week 24; n=8, 10, 7, 4, 4, 4 -0.1  (0.5) 0.1  (0.2) -0.2  (0.5) -0.1  (0.4) 0.3  (0.5) -0.3  (0.3)
Week 48; n=8, 11, 7, 4, 3, 4 -0.1  (0.4) 0.1  (0.2) 0.1  (0.5) -0.1  (0.2) 0.2  (0.3) 0.1  (0.3)
17.Primary Outcome
Title Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Complement Activation (CH50) at Week 24 (FTP) and Week 48 (STP)
Hide Description Blood samples of participants were collected for CH50 prior to and 2 hours after dosing, and the samples were sent to a Central Laboratory for analysis: Bio Analytical Research Corporation (BARC). Change from Baseline (Week 0 for the FTP; Week 24 for the STP) was calculated as the value at Weeks 24 (FTP) and 48 (STP) minus the value at Baseline. Ofa depletes (induces the cell death of) B cells. When Ofa binds to a B cell, it induces complement CH50, which in turn causes cell death via cytotoxicity. Therefore, the CH50 levels were measured to ensure that CH50 was being appropriately activated.
Time Frame FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)
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Hide Analysis Population Description
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Overall Number of Participants Analyzed 8 7 0 4 2 0
Mean (Standard Deviation)
Unit of Measure: Units per milliliter
Week 24; n=8, 7, 0, 4, 2, 0 -0.6  (4.1) -7.1  (12.9) 2.8  (9.1) -19.5  (24.7)
Week 48; n=4, 0, 0, 1, 0, 0 3.8  (7.8) NA [1]   (NA) -31.0  (0) NA [1]   (NA)
[1]
Data were not collected for this cohort.
18.Secondary Outcome
Title Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)
Hide Description The MRI scan was performed prior to dosing and could be performed up to 4 days prior to Visits 3 and 10. An IDMC reviewed the data. T1 enhancing Ls are enhanced by gadolinium, are considered representative of disease activity/inflammation, and may signify a relapse. Measurement of these Ls is comparative from visit to visit. "Total T1 enhancing Ls" represent the total of the new T1 enhancing Ls over the entire study period. T2 L measurements measure all Ls on the brain in terms of volume and size, measuring for new or enlarging Ls. T1 hypointensive Ls are areas of permanent damage.
Time Frame FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
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Hide Analysis Population Description
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
Overall Number of Participants Analyzed 8 11 7 4 4 4
Mean (Standard Deviation)
Unit of Measure: lesions
Week 24, New (N) T1 enhancing Ls; n=8,11,7,4,4, 4 0.13  (0.35) 0  (0) 0  (0) 3.06  (4.66) 23.50  (43.0) 2.50  (3.32)
Week 24, Total T1 enhancing Ls; n=8,11,7,4,4,4 0.13  (0.35) 0.09  (0.30) 0  (0) 3.63  (5.02) 25.75  (46.23) 4.50  (7.14)
Week 24, N and/or enlarging T2 Ls; n=8,11,7,4,4,4 0.25  (0.71) 0.09  (0.30) 0  (0) 4.00  (6.52) 25.00  (46.03) 3.00  (4.24)
Week 24, N T1 hypointense Ls; n=8,11,7,4, 4,4 0  (0) 0.27  (0.47) 0.29  (0.49) 1.50  (3.00) 5.00  (9.35) 0.25  (0.50)
Week 48, N T1 enhancing Ls; n=8,10,7,4,3,4 0.13  (0.35) 0  (0) 0.29  (0.76) 0  (0) 0.33  (0.58) 0  (0)
Week 48, Total T1 enhancing Ls; n=8,10,7,4,3,4 0.13  (0.35) 0  (0) 0.43  (1.13) 0  (0) 3.00  (5.20) 0  (0)
Week 48, N and/or enlarging T2 Ls; n=8,10,7,4, 3,4 0.13  (0.35) 0  (0) 0.29  (0.76) 0  (0) 0.33  (0.58) 0  (0)
Week 48, N T1 hypointense Ls; n=8,10,7,4,3,4 0  (0) 0  (0) 0  (0) 0  (0) 3.00  (4.36) 0  (0)
Week 104, N T1 enhancing Ls; n=1, 0, 0, 0, 0, 0 0.0 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Week 104, Total T1 enhancing Ls; n=1, 0, 0, 0, 0,0 0.0 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Week 104, N and /or enlarging T2 Ls; n=1,0,0,0,0,0 0.0 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Week 104, N T1 hypointense Ls; n=1, 0, 0, 0, 0, 0 0.0 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
[1]
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
[2]
No participants were analyzed in this treatment arm at this time point.
19.Secondary Outcome
Title Total Volume of T2 Lesions at Week 24 and Week 48
Hide Description The MRI scan should be performed prior to dosing and can be performed up to 4 days prior to Visits 3 and 10. An IDMC reviewed the data. The volume of T2 lesions was not a cumulative volume, but the volume measured at Visit 10 and Visit 17. T2 lesion measurements measure all lesions on the brain in terms of volume and size, measuring for new lesions or enlarging lesions.
Time Frame Visit 10 (Week 24) and Visit 17 (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Overall Number of Participants Analyzed 8 11 7 4 4 4
Mean (Standard Deviation)
Unit of Measure: millimeters cubed
Week 24; n=8, 11, 7, 3, 4, 4 7898  (8802) 10323  (8281) 17399  (11641) 11290  (11746) 12194  (18008) 15039  (8984)
Week 48; n=8, 10, 7, 4, 3, 4 7791  (8878) 11304  (8269) 17566  (12413) 10684  (8903) 18164  (23696) 15166  (9060)
20.Secondary Outcome
Title Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions
Hide Description The peripheral blood for each participant was collected and analyzed for the concentration of the drug in serum. There were four infusions in the study; the third infusion at Visit 10 represents the first infusion of the second treatment period (Weeks 24-48). Data are presented for the predose concentrations.
Time Frame Visit 3 (Week 0), Visit 4 (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Overall Number of Participants Analyzed 8 10 6 4 4 4
Mean (Standard Deviation)
Unit of Measure: milligrams per liter
Week 0; n=8, 10, 6, 0, 0, 0 32.3  (9.65) 85.8  (53.7) 176  (24.2) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
Week 2; n=8, 10, 6, 0, 0, 0 23.4  (19.9) 64.9  (67.1) 174  (187) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
Week 24; n=0, 0, 0, 4, 3, 4 NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) 28.9  (8.03) 43.4  (67.9) 72.7  (128)
Week 26; n=0, 0, 0, 4, 3, 4 NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) 21.6  (18.5) 47.7  (76.9) 82.4  (144)
[1]
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
[2]
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
21.Secondary Outcome
Title The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
Hide Description The peripheral blood for each participant was collected and analyzed for Cmax after the first, second, third, and fourth i.v. infusions. Assessment was performed using the noncompartmental method (this analysis is highly dependent on the estimation of total drug exposure).
Time Frame Visit 3 (Week 0), Visit 4, (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Overall Number of Participants Analyzed 8 10 6 4 3 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: milligrams per liter
Week 0; n=8, 10, 6, 0, 0, 0
36.8
(13.1%)
124
(23.6%)
346
(24.0%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
Week 2; n=8, 10, 6, 0, 0, 0
47.7
(14.7%)
157
(25.9%)
452
(28.5%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
Week 24; n=0, 0, 0, 4, 3, 4
NA [2] 
(NA%)
NA [2] 
(NA%)
NA [2] 
(NA%)
33.2
(13.7%)
137
(40.7%)
312
(24.5%)
Week 26; n=0, 0, 0, 4, 3, 4
NA [2] 
(NA%)
NA [2] 
(NA%)
NA [2] 
(NA%)
43.5
(25.2%)
210
(54.1%)
416
(24.6%)
[1]
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
[2]
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
22.Secondary Outcome
Title The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
Hide Description The peripheral blood for each participant was collected and analyzed to estimate the area under the plasma concetration-time curve, AUC(0-t), and was assessed using the non-compartmental method.
Time Frame Visit 3 (Week 0), Visit 4 (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour (hr) after infusion, and 2 hours after infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Overall Number of Participants Analyzed 8 10 6 4 3 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Millgram hour per liter
Week 0; n=8, 10, 6, 0, 0, 0
153
(19.4%)
498
(18.6%)
1528
(20.7%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
Week 2; n=8, 10, 6, 0, 0, 0
15559
(34.4%)
63165
(40.6%)
225876
(30.4%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
Week 24; n=0, 0, 0, 4, 3, 4
NA [2] 
(NA%)
NA [2] 
(NA%)
NA [2] 
(NA%)
123
(8.6%)
624
(32.7%)
1347
(29.1%)
Week 26; n=0, 0, 0, 4, 3, 4
NA [2] 
(NA%)
NA [2] 
(NA%)
NA [2] 
(NA%)
12763
(29.3%)
71041
(54.9%)
217757
(44.5%)
[1]
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
[2]
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
23.Secondary Outcome
Title Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
Hide Description The peripheral blood for each participant was collected and analyzed for tmax.
Time Frame Visit 3 (Week 0), Visit 4 (Week 2),Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Overall Number of Participants Analyzed 8 10 6 4 3 4
Median (Full Range)
Unit of Measure: hours
Week 0; n=8, 10, 6, 0, 0, 0
5.33
(4.00 to 8.60)
5.88
(4.17 to 7.67)
6.00
(5.17 to 9.42)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Week 2; n=8, 10, 6, 0, 0, 0
4.25
(3.42 to 5.58)
4.33
(3.52 to 6.13)
3.83
(3.67 to 4.50)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Week 24; n=0, 0, 0, 4, 3, 4
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
4.42
(4.08 to 6.00)
6.00
(4.17 to 6.92)
6.54
(4.13 to 8.17)
Week 26; n=0, 0, 0, 4, 3, 4
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
3.67
(3.58 to 6.00)
5.17
(4.08 to 5.50)
4.50
(3.75 to 5.50)
[1]
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
[2]
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
24.Secondary Outcome
Title Clearance of Ofa Over the Course of Weeks 0-2 and 24-26
Hide Description The peripheral blood for each participant was collected and analyzed for clearance. Clearance is the measure of efficiency with which a drug is irreversibly removed form the body. The average clearance over the course of Weeks 0-2 and 24-26 is reported.
Time Frame Weeks 0-2 and 24-26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Overall Number of Participants Analyzed 8 10 6 4 3 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: liters per hour
Weeks 0-2; n=8, 10, 6, 0, 0, 0
0.006
(34.2%)
0.005
(41.0%)
0.003
(30.8%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
Weeks 24-26; n=0, 0, 0, 4, 3, 4
NA [2] 
(NA%)
NA [2] 
(NA%)
NA [2] 
(NA%)
0.008
(29.5%)
0.004
(54.4%)
0.03
(44.4%)
[1]
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
[2]
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
25.Secondary Outcome
Title The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26
Hide Description The peripheral blood for each participant was collected and analyzed for Vss. The average Vss over the course of Weeks 0-2 and 24-26 is reported.
Time Frame Weeks 0-2 and 24-26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants who contributed data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Overall Number of Participants Analyzed 8 10 6 4 3 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: liters
Weeks 0-2; n=8, 10, 6, 0, 0, 0
2.48
(20.4%)
2.61
(42.0%)
2.19
(21.3%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
Weeks 24-26; n=0, 0, 0, 4, 3, 4
NA [2] 
(NA%)
NA [2] 
(NA%)
NA [2] 
(NA%)
2.74
(6.54%)
2.20
(68.0%)
2.15
(20.8%)
[1]
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
[2]
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
26.Secondary Outcome
Title Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26
Hide Description The peripheral blood for each participant was collected and analyzed for half life. Half life is defined as the period of time required for the amount of drug in the body to be reduced by half. The average t1/2 over the course of Weeks 0-2 and 24-26 is reported.
Time Frame Weeks 0-2 and 24-26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants who contributed data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description:
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
Overall Number of Participants Analyzed 8 10 6 4 3 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
Weeks 0-2; n=8, 10, 6, 0, 0, 0
246
(16.1%)
331
(35.2%)
452
(28.4%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
Weeks 24-26; n=0, 0, 0, 4, 3, 4
NA [2] 
(NA%)
NA [2] 
(NA%)
NA [2] 
(NA%)
241
(23.6%)
342
(16.3%)
453
(49.9%)
[1]
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
[2]
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
Time Frame Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
Adverse Event Reporting Description The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
 
Arm/Group Title 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Hide Arm/Group Description Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination. Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination. Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination. Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
All-Cause Mortality
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   2/11 (18.18%)   0/7 (0.00%)   1/4 (25.00%)   0/4 (0.00%)   0/4 (0.00%) 
Blood and lymphatic system disorders             
Anaemia  1  0/8 (0.00%)  1/11 (9.09%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Infections and infestations             
Influenza  1  0/8 (0.00%)  0/11 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%) 
Nervous system disorders             
Headache  1  0/8 (0.00%)  1/11 (9.09%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo 300 mg Ofa/Matching Placebo 700 mg Ofa/Matching Placebo Matching Placebo/100 mg Ofa Matching Placebo/300 mg Ofa Matching Placebo/700 mg Ofa
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   10/11 (90.91%)   7/7 (100.00%)   3/4 (75.00%)   4/4 (100.00%)   4/4 (100.00%) 
Blood and lymphatic system disorders             
Leukopenia  1  1/8 (12.50%)  0/11 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  1/4 (25.00%) 
Lymphopenia  1  1/8 (12.50%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Neutropenia  1  0/8 (0.00%)  0/11 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Iron deficiency anaemia  1  0/8 (0.00%)  0/11 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Cardiac disorders             
Ventricular extrasystoles  1  0/8 (0.00%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Ear and labyrinth disorders             
Vertigo  1  1/8 (12.50%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Eye disorders             
Abnormal sensation in eye  1  1/8 (12.50%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Vision blurred  1  0/8 (0.00%)  1/11 (9.09%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Blepharospasm  1  0/8 (0.00%)  0/11 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%) 
Visual impairment  1  0/8 (0.00%)  0/11 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Gastrointestinal disorders             
Nausea  1  1/8 (12.50%)  1/11 (9.09%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Vomiting  1  0/8 (0.00%)  0/11 (0.00%)  1/7 (14.29%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%) 
Diarrhoea  1  1/8 (12.50%)  1/11 (9.09%)  1/7 (14.29%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%) 
Flatulence  1  0/8 (0.00%)  1/11 (9.09%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Abdominal pain upper  1  0/8 (0.00%)  1/11 (9.09%)  1/7 (14.29%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Constipation  1  0/8 (0.00%)  0/11 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Abdominal discomfort  1  0/8 (0.00%)  1/11 (9.09%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Neck pain  1  1/8 (12.50%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
General disorders             
Fatigue  1  2/8 (25.00%)  2/11 (18.18%)  0/7 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%) 
Pyrexia  1  1/8 (12.50%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Immune system disorders             
Cytokine release syndrome  1  0/8 (0.00%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/4 (50.00%)  0/4 (0.00%) 
Infections and infestations             
Upper respiratory tract infection  1  1/8 (12.50%)  2/11 (18.18%)  2/7 (28.57%)  3/4 (75.00%)  0/4 (0.00%)  0/4 (0.00%) 
Nasopharyngitis  1  4/8 (50.00%)  0/11 (0.00%)  1/7 (14.29%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%) 
Rhinitis  1  0/8 (0.00%)  1/11 (9.09%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Laryngitis  1  0/8 (0.00%)  0/11 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%) 
Tonsilitis  1  0/8 (0.00%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Tracheobronchitis  1  1/8 (12.50%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Viral infection  1  1/8 (12.50%)  3/11 (27.27%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Influenza  1  0/8 (0.00%)  0/11 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  1/4 (25.00%)  0/4 (0.00%) 
Varicella  1  0/8 (0.00%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Acute tonsillitis  1  0/8 (0.00%)  1/11 (9.09%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Oral herpes  1  0/8 (0.00%)  1/11 (9.09%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Urinary tract infection  1  0/8 (0.00%)  1/11 (9.09%)  0/7 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Injury, poisoning and procedural complications             
Wound  1  0/8 (0.00%)  0/11 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Contusion  1  1/8 (12.50%)  0/11 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Concussion  1  0/8 (0.00%)  0/11 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  1/4 (25.00%) 
Investigations             
False positive laboratory result  1  0/8 (0.00%)  1/11 (9.09%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Blood bicarbonate decreased  1  1/8 (12.50%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Blood creatinine increased  1  1/8 (12.50%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Alanine aminotransferase increased  1  0/8 (0.00%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Musculoskeletal and connective tissue disorders             
Back pain  1  1/8 (12.50%)  1/11 (9.09%)  0/7 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%) 
Nervous system disorders             
Headache  1  1/8 (12.50%)  1/11 (9.09%)  0/7 (0.00%)  1/4 (25.00%)  1/4 (25.00%)  0/4 (0.00%) 
Dizziness  1  1/8 (12.50%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Burning sensation  1  1/8 (12.50%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Trigeminal neuralgia  1  0/8 (0.00%)  1/11 (9.09%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Hypoaesthesia facial  1  1/8 (12.50%)  0/11 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Neuralgia  1  0/8 (0.00%)  0/11 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Tension headache  1  0/8 (0.00%)  0/11 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Oropharyngeal pain  1  0/8 (0.00%)  0/11 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%) 
Psychiatric disorders             
Depression  1  2/8 (25.00%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Insomnia  1  0/8 (0.00%)  1/11 (9.09%)  0/7 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%) 
Anxiety  1  0/8 (0.00%)  0/11 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%) 
Depressed mood  1  0/8 (0.00%)  1/11 (9.09%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Throat irritation  1  3/8 (37.50%)  4/11 (36.36%)  2/7 (28.57%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Rhinorrhoea  1  0/8 (0.00%)  1/11 (9.09%)  1/7 (14.29%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Sneezing  1  0/8 (0.00%)  1/11 (9.09%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Asthma  1  0/8 (0.00%)  1/11 (9.09%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Bronchospasm  1  0/8 (0.00%)  1/11 (9.09%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Wheezing  1  1/8 (12.50%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Dyspnoea  1  1/8 (12.50%)  0/11 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Cough  1  0/8 (0.00%)  1/11 (9.09%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Nasal congestion  1  0/8 (0.00%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Pharyngeal edema  1  0/8 (0.00%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders             
Rash  1  2/8 (25.00%)  3/11 (27.27%)  4/7 (57.14%)  2/4 (50.00%)  0/4 (0.00%)  2/4 (50.00%) 
Erythema  1  2/8 (25.00%)  1/11 (9.09%)  1/7 (14.29%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Rash erythematous  1  0/8 (0.00%)  1/11 (9.09%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Pruritus generalized  1  0/8 (0.00%)  0/11 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Rash pruritic  1  0/8 (0.00%)  1/11 (9.09%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Urticaria  1  0/8 (0.00%)  1/11 (9.09%)  1/7 (14.29%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%) 
Hyperhidrosis  1  0/8 (0.00%)  1/11 (9.09%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Petechiae  1  0/8 (0.00%)  1/11 (9.09%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Rash generalized  1  0/8 (0.00%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Acne  1  0/8 (0.00%)  1/11 (9.09%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Pruritus  1  0/8 (0.00%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Anemia  1  0/8 (0.00%)  1/11 (9.09%)  1/7 (14.29%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Surgical and medical procedures             
Tooth extraction  1  0/8 (0.00%)  0/11 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Bartholin's cyst removal  1  0/8 (0.00%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Antibiotic prophylaxis  1  0/8 (0.00%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Vascular disorders             
Flushing  1  0/8 (0.00%)  2/11 (18.18%)  1/7 (14.29%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Hypotension  1  1/8 (12.50%)  0/11 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00640328    
Obsolete Identifiers: NCT01526993
Other Study ID Numbers: 115102
First Submitted: March 18, 2008
First Posted: March 21, 2008
Results First Submitted: November 1, 2012
Results First Posted: December 4, 2012
Last Update Posted: April 11, 2017